Study of XL999 in Adults With Solid Tumors

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL999 Administered Intravenously to Subjects With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00104117

Enrollment

Registered

2005-02-24

Start date

2004-11-30

Completion date

2008-10-31

Last updated

2010-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

The purpose of this study is to assess the safety and tolerability of XL999 in adults with advanced solid tumors.

Interventions

DRUGXL999

XL999 was to be given biweekly to an initial cohort of subjects at 0.20 mg/kg and to successive cohorts at doses that escalated by cohort according to a design for safely determining an MTD. After determination of the MTD, one or more additional cohorts were to receive XL999 weekly at the MTD or a lower dose, as determined by the CRC on the basis of interim safety and PK data. By a protocol amendment after initiation of the study, subjects were to be enrolled in an additional cohort to receive a weekly XL999 dose of 200 mg.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Advanced solid tumor * Cancer that has progressed on currently available therapies * Life expectancy of \>3 months * Adequate bone marrow, liver, and kidney function * Willing to use accepted method of contraception during the course of the study * Negative pregnancy test (females) * Written informed consent

Exclusion criteria

* Chemotherapy within 4-6 weeks of the start of treatment (depending on the therapy) * Radiotherapy within 4 weeks of the start of treatment * Subjects with known brain metastasis * Uncontrolled medical disorder such as infection or cardiovascular disease * Subjects known to be HIV positive * Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of XL999 administered as a single 4-hour intravenous (IV) infusion in subjects with solid tumors	Inclusion until 30 days post last treatment

Secondary

Measure	Time frame
To evaluate plasma pharmacokinetics (PK) and estimate renal elimination of XL999 administered as a single 4-hour IV infusion in subjects with solid tumors	Various timepoints from pre-dosing until 48 hours post dose.
To evaluate the PK of XL999 administered at a fixed weekly dose of 200 mg.	At various timepoints from pre-dosing until 48 hours post dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026